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Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Foot Ulcer:a Randomized Controlled Trial

Primary Purpose

Diabetic Foot

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Platelet Fibrin Plasma
Platelet Rich Plasma
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring Diabetes foot ulcer, Platelet Rich Plasma, Platelet Fibrin Plasma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient is aged 18-80 years old; Diagnosed as type 1 or type 2 diabetes according to the World Health Organization standard, blood sugar has been controlled before enrollment, and the level of Glycated hemoglobin HbA1c is less than 10%; diabetes wounds with poor healing or prolonged healing need standard wound treatment; There is no disseminated infection or the disseminated infection has been controlled; After preparing the wound bed, the condition for using platelet plasma to close the wound is met; Voluntarily sign an informed consent form; Exclusion Criteria: Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet; Severe ischemia of the wound surface, unable to seek medical attention or not yet corrected; Uncontrolled systemic or disseminated infections; Blood glucose is out of control or not yet effectively controlled; Blood system diseases with uncorrected coagulation dysfunction or platelet dysfunction; There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented; Platelets ≤ 80 × 10^9, hemoglobin<90g/L; Patients with advanced malignant tumors; Active period of autoimmune diseases; The patient is unable to cooperate or has mental disorders; According to the judgment of the researchers, the patient has a clear and irremovable cause that affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Platelet Fibrin Plasma

    Platelet Rich Plasma

    Arm Description

    Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.

    Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.

    Outcomes

    Primary Outcome Measures

    4-week wound healing rate
    By D28, the proportion of healed wounds in the total number of cases

    Secondary Outcome Measures

    Full Information

    First Posted
    July 29, 2023
    Last Updated
    July 29, 2023
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05979584
    Brief Title
    Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Foot Ulcer:a Randomized Controlled Trial
    Official Title
    Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Foot Ulcer:a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this randomized control trial is to compare the efficacy and safety of Platelet Rich Plasma VS Platelet Fibrin Plasma in patients with diabetes foot ulcer. The main question it aims to answer are: Whether the Platelet Fibrin Plasma have noninferior efficacy than Platelet Rich Plasma in treatment of diabetes foot ulcer? Whether the Platelet Fibrin Plasma have noninferior safety than Platelet Rich Plasma in treatment of diabetes foot ulcer? Participants will be assigned with a 1:1 ratio into intervention group and control group. Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Foot
    Keywords
    Diabetes foot ulcer, Platelet Rich Plasma, Platelet Fibrin Plasma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Platelet Fibrin Plasma
    Arm Type
    Experimental
    Arm Description
    Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.
    Arm Title
    Platelet Rich Plasma
    Arm Type
    Placebo Comparator
    Arm Description
    Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.
    Intervention Type
    Device
    Intervention Name(s)
    Platelet Fibrin Plasma
    Intervention Description
    Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.
    Intervention Type
    Device
    Intervention Name(s)
    Platelet Rich Plasma
    Intervention Description
    Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.
    Primary Outcome Measure Information:
    Title
    4-week wound healing rate
    Description
    By D28, the proportion of healed wounds in the total number of cases
    Time Frame
    4-week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient is aged 18-80 years old; Diagnosed as type 1 or type 2 diabetes according to the World Health Organization standard, blood sugar has been controlled before enrollment, and the level of Glycated hemoglobin HbA1c is less than 10%; diabetes wounds with poor healing or prolonged healing need standard wound treatment; There is no disseminated infection or the disseminated infection has been controlled; After preparing the wound bed, the condition for using platelet plasma to close the wound is met; Voluntarily sign an informed consent form; Exclusion Criteria: Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet; Severe ischemia of the wound surface, unable to seek medical attention or not yet corrected; Uncontrolled systemic or disseminated infections; Blood glucose is out of control or not yet effectively controlled; Blood system diseases with uncorrected coagulation dysfunction or platelet dysfunction; There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented; Platelets ≤ 80 × 10^9, hemoglobin<90g/L; Patients with advanced malignant tumors; Active period of autoimmune diseases; The patient is unable to cooperate or has mental disorders; According to the judgment of the researchers, the patient has a clear and irremovable cause that affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.

    12. IPD Sharing Statement

    Learn more about this trial

    Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Foot Ulcer:a Randomized Controlled Trial

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